The U.S. FDA has granted breakthrough device designation to Salvia Bioelectronics BV for its implantable neurostimulation system to treat chronic migraine. The designation, which provides for priority review and consultation with the agency on product development, underscores the need for effective treatments for the costly and debilitating condition. According to a summary in a patent filing, the wireless system comprises a treatment pulse generator unit and an implantable electrode unit to provide neurostimulation therapy for headaches.
Perkinelmer Inc. is looking to bolster its life sciences offerings with the purchase of cell engineering company Horizon Discovery Group plc for $383 million. The all-cash acquisition will add gene-editing and gene-modulation tools to Perkinelmer’s existing portfolio of discovery and applied genomics solutions. Headquartered in Cambridge, U.K., Horizon provides CRISPR and RNA interference (RNAi) reagents, cell models, cell engineering and based editing products to aid in drug discovery and development.
Illumina Inc. crushed analysts’ estimates for the third quarter, posting revenue of $794 million vs. the Street consensus of $716 million. Driving results were sequencing consumables, which racked up $500 million in the period, with clinical sequencing hitting 96% of pre-COVID-19 levels, up from 84% in the second quarter.
Teleflex Inc. reeled in $628.3 million in revenue in the third quarter, down 3.1% from the same period last year but ahead of the Street’s estimate of $619.4 million. Earnings per share also beat consensus, at $2.46 vs. $2.24. The release of the quarterly results dovetailed with Teleflex’s reveal of a definitive agreement to acquire hemostatic products company Z-Medica LLC for up to $525 million.
Keeping you up to date on recent developments in diagnostics, including: A case for pooled testing of SARS-CoV-2; FIT as effective as colonoscopy in ruling out suspected colorectal cancer; Looking to comparative genomics analysis to explain COVID-19 susceptibility.
Neuroem Therapeutics Inc. has received breakthrough device designation from the U.S. FDA for Memorem, a bioengineered, wearable head device for the treatment of Alzheimer’s disease. The breakthrough nod, which entitles companies to an expedited regulatory process, follows results from a pilot study showing Memorem can reverse memory loss in patients with the debilitating brain disorder.
Shares of early cancer detection company Exact Sciences Corp. soared Tuesday morning on news it is acquiring two liquid biopsy screening companies, Thrive Earlier Detection Corp. and Base Genomics Ltd., for $2.56 billion and selling $869 million of common stock to institutional investors.
Abiomed Inc. has won the U.S. FDA’s nod for its Breethe Oxy-1 device, an all-in-one, compact cardiopulmonary bypass system designed for easy mobility. The company plans a controlled release at U.S. hospitals between now and March of 2021, with widespread availability later that year.
Neuromod Devices Ltd., which is developing an at-home, self-managed treatment for tinnitus, closed a €10.5 million (US$12.4 million) series B financing led by majority investor Fountain Healthcare Partners. The funds are earmarked for expanding European commercialization of the Lenire tinnitus treatment device, to scale up manufacturing, progress U.S. FDA regulatory approval and pursue opportunities with the U.S. Department of Veterans Affairs (VA).
Keeping you up to date on recent developments in diagnostics, including: Study underscores long-term impact of COVID-19; CT scan enhancement via deep learning; Caution in screening for large fetus size.
